NCT01682876

Immunogenicity, Safety and 1 Year Persistence of Antibodies After Either One or Two Doses of Meningococcal ACWY Conjugate Vaccine in Healthy Children 2 Through 10 Years of Age.

A Phase 3b, Randomized, Observer-Blind, Placebo-Controlled Multi-Center Study Comparing Immunogenicity, Safety and 1 Year Persistence of Antibodies After Either One or Two Doses of Novartis Meningococcal ACWY Conjugate Vaccine, Administered to Healthy Children 2 to 10 Years of Age.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 715 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 2 Years – 10 Years
• Healthy volunteers: Accepted

Summary

This study was designed to conduct a comparative trial to further evaluate the safety, immunogenicity and antibody persistence of two doses of Novartis MenACWY conjugate vaccine, given 2 months apart, versus one dose of Novartis MenACWY conjugate vaccine in children 2 through 10 years of age.

Conditions

• Meningococcal Disease
• Infections, Meningococcal

Interventions

Type	Name	Description
BIOLOGICAL	MenACWY-CRM	The investigational meningococcal (groups A, C, Y, and W-135 vaccine) oligosaccharide diphtheria CRM197 conjugate vaccine (MenACWY-CRM) was administered intramuscularly in the nondominant arm

Timeline

• Start date: 2012-10-07
• Primary completion: 2013-07-02
• Completion: 2014-05-30
• First posted: 2012-09-11
• Last updated: 2019-06-14
• Results posted: 2014-10-06

Locations

19 sites across 1 country: United States